A study assessing clinical aspects of pregnancy, delivery and perinatal outcomes in women with intrahepatic cholestasis of pregnancy

Not Applicable

• Conditions: Intrahepatic cholestasis of pregnancy; Pregnancy and Childbirth; Liver disorders in pregnancy, childbirth and the puerperium

• Registration Number: ISRCTN21187408
• Lead Sponsor: icolae Testemi?anu State University of Medicine and Pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 15 June 2020
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. ICP (pruritus with a raised serum bile acid above 10 µmol/l) for the main group
2. Absence of ICP (absence of pruritus and normal serum bile acid (below 10 µmol/l)) for the control group
3. At least 22+0 weeks of gestation on day of recruitment
4. No known lethal fetal anomaly
5. Aged 18 years or over
6. Able to give written informed consent

Exclusion Criteria

1. Women with known liver disease: acute viral hepatitis, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis, primary biliary cirrhosis, symptomatic cholelithiasis, cytomegalovirus, Epstein-Barr virus, acute fatty liver of the pregnancy, drug-induced hepatitis
2. Women diagnosed with preeclampsia, HELLP syndrome and congenital thrombophilia

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome of perinatal morbidity and mortality, preterm delivery or neonatal admission for at least 4 hours; measured from patient medical notes between randomisation and 7 days post-delivery (death), or to discharge (neonatal unit admission)